The RNA-based panel detects leukemia-associated gene fusions at levels as low as 1% tumor cells, offering another approach to monitoring residual disease.
OGT has launched the SureSeq myPanel Myeloid Fusion MRD Panel, introducing the first dedicated fusion measurable residual disease (MRD) next-generation sequencing (NGS) panel for acute myeloid leukemia (AML) to the commercial market.
The RNA-based NGS assay, developed in collaboration with Roswell Park Comprehensive Cancer Center through OGT’s custom panel service, is designed to detect AML-associated fusion events and identify MECOM expression levels at MRD-level sensitivity in a single test. Genomic AML testing workflows have traditionally covered limited portions of the disease landscape, leaving critical structural variants and fusion events undetected when relying on routine DNA profiling alone.
“Important fusion signals are difficult to identify when workflows depend on multiple assays or have insufficient sensitivity,” says Adrian Smith, CEO at OGT, in a release. “We’re proud to launch the first dedicated Fusion MRD NGS panel for AML that empowers laboratories with a focused tool to detect, analyse and track fusion events at MRD-level sensitivity. Used independently or alongside our SureSeq Myeloid MRD Plus NGS Panel, this panel has the potential to capture a wide range of disease-associated fusion events at MRD-levels of sensitivity that may otherwise be missed, and thus provides a broader genomic profile of AML samples for deeper insights.”
Detection Down to 1% Tumor Cells
In an initial clinical research evaluation conducted at Roswell Park Comprehensive Cancer Center, the SureSeq myPanel Fusion MRD NGS workflow detected key disease-associated fusions—including BCR::ABL1 and PML::RARA—in serial dilutions down to 1% tumor cells.
The ability to target RNA fusions helps address diagnostic gaps in patient cohorts that do not present informative DNA mutations, enabling clinical teams to track disease dynamics over multiple timepoints.
“The addition of RNA fusion detection represents an important opportunity to broaden the reach of molecular MRD assessment to the approximately 20–25% of AML cases associated with fusion-driven disease,” says Sean Glenn, director of the advanced molecular diagnostics laboratory at Roswell Park Comprehensive Cancer Center, in a release. “By providing molecular markers of residual leukaemia that can be monitored over time, fusion transcripts can support residual disease assessment, including in samples that lack an informative DNA mutation.”
Workflow and Software Integration
The panel functions as a standalone assay or can be combined with the SureSeq Myeloid MRD Plus NGS Panel. When paired, the workflows allow laboratories to evaluate single nucleotide variants , insertions and deletions, internal tandem duplications, and RNA fusion events without having to run multiple single-analyte assays.
Data generated by the panel is supported by OGT’s complimentary NGS analysis software, Interpret, which allows laboratories to analyze, track, and visualize variants across multiple longitudinal timepoints within one system. The software is available via cloud or local installations and supports integration with third-party platforms, such as QIAGEN Clinical Insight Interpret, to streamline data interpretation in clinical research settings.
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